neurology

Amylyx preps filing for its ALS drug after FDA feedback

Just a few months ago, Amylyx was talking about having to complete another clinical trial before it could file for FDA approval of its drug for neurodegenerative disease amyotrophic lateral sclerosis (ALS). It’s now accelerating those plans, citing favourable discussions with the US regulator. The company revealed today that it will submit its marketing application …

Amylyx preps filing for its ALS drug after FDA feedback Read More »

First subject dosed in psilocybin trial for rare headache disorder

The first patient has received a low dose of Beckley Psytech’s psychedelic medicine psilocybin in a clinical trial for short-lasting unilateral neuralgiform headache attacks (SUNHA), a rare disorder. The UK company says that SUNHA is a debilitating condition that is estimated to affect 40,000 patients in US and Europe. It is characterised by short, extremely …

First subject dosed in psilocybin trial for rare headache disorder Read More »

Startup Neuroglee raises $10m for virtual neurology clinics

A digital health company focusing on neurodegenerative disorders – Neuroglee Therapeutics – has raised $10 million in first-round funding to roll out a virtual neurology clinics for people with cognitive problems caused by dementia. The Singapore startup, which is partnering with the Mayo Clinic on the clinics, said the cash injection will also go towards …

Startup Neuroglee raises $10m for virtual neurology clinics Read More »

Server cans autism hope bumetanide after phase 3 fails

Servier and Neurochlore have been forced to admit defeat in their bid to bring the first drug to market for people with autism spectrum disorder (ASD), after a comprehensive fail for their bumetanide candidate in two phase 3 trials. The French partners said today that there was “no sign of effectiveness” for bumetanide compared to …

Server cans autism hope bumetanide after phase 3 fails Read More »

AC Immune claims half a win for tau drug in Alzheimer’s trial

Shares in AC Immune leaped today after the company said its tau-targeting Alzheimer’s disease candidate semorinemab hit one of its objectives in a phase 2 trial, although it missed another. The Swiss biotech’s Nasdaq-listed shares were up around 66% shortly after the announcement of data from the LAURIET study in patients with mild-to-moderate Alzheimer’s disease, …

AC Immune claims half a win for tau drug in Alzheimer’s trial Read More »

Beckley Psytech raises $80m for psychedelic meds development

UK psychedelic medicine specialist Beckley Psytech has raised an impressive £58 million (around $80 million) in an oversubscribed second-round financing that will help fund clinical development of its psilocybin-based therapies. The Oxford-based company had originally hoped to raise $50 million from the series B, and the scale of the financing is further evidence that repurposing …

Beckley Psytech raises $80m for psychedelic meds development Read More »

Lilly sets out its stall on donanemab as filing approaches

The FDA’s approval of Biogen’s Aduhelm for Alzheimer’s disease emboldened Eli Lilly to move forward plans to file its own candidate donanemab later this year, although it has acknowledged it will have to overcome reservations about anti-amyloid drugs. Lilly’s chief scientific officer Dan Skovronsky said on the company’s second-quarter results call that the results of …

Lilly sets out its stall on donanemab as filing approaches Read More »

AbbVie, Calico raise their age-related disease alliance funding to $3.5bn

AbbVie and Alphabet spin-out Calico Life Sciences have agreed to fund their seven-year-old partnership seeking treatments for diseases of ageing with another $500 million apiece. The collaboration with Google sister company Calico – formed in 2014 with $1.5 billion in funding and extended in 2018 with another $1 billion top up – has already resulted …

AbbVie, Calico raise their age-related disease alliance funding to $3.5bn Read More »

AbbVie, Calico raise their age-related disease alliance funding to $3.5bn

AbbVie and Alphabet spin-out Calico Life Sciences have agreed to fund their seven-year-old partnership seeking treatments for diseases of ageing with another $500 million apiece. The collaboration with Google sister company Calico – formed in 2014 with $1.5 billion in funding and extended in 2018 with another $1 billion top up – has already resulted …

AbbVie, Calico raise their age-related disease alliance funding to $3.5bn Read More »

Biogen bites back at critics of Aduhelm after drug’s slow start

Biogen has reported $2m in sales for newly-launched Alzheimer’s therapy Aduhelm that came in below its expectations, prompting the company to issue a rebuke to what it says is “extensive misinformation and misunderstanding” about the drug. In an open letter, R&D chief Al Sandrock tackled a number of the criticisms levelled at the FDA’s decision …

Biogen bites back at critics of Aduhelm after drug’s slow start Read More »

Roche ‘talking to FDA’ as Alzheimer’s drug moves towards 2022 readout

Phase 3 results with Roche’s amyloid-targeting Alzheimer’s drug gantenerumab may not be due until the second half of last year, but the company is already in discussions with the FDA about a route to approval. There has been speculation since the unexpected approval of Biogen and Eisai’s Aduhelm (aducanumab) last month that other amyloid therapies …

Roche ‘talking to FDA’ as Alzheimer’s drug moves towards 2022 readout Read More »

FDA gives speedy review to Bayer’s Parkinson’s stem cell therapy

Bayer subsidiary BlueRock Therapeutics has been granted a fast-track review by the FDA for DA01, its stem cell-based therapy for Parkinson’s disease which is currently in early-stage clinical testing. The FDA designation allows for benefits such as more frequent meetings and communication with the regulator during clinical development, and a truncated six-month review time. Those …

FDA gives speedy review to Bayer’s Parkinson’s stem cell therapy Read More »

Ipsen tries again in Parkinson’s disease with $363m IRLAB deal

French drugmaker Ipsen has made another foray into the Parkinson’s disease category, licensing rights to an oral dopamine D3 receptor antagonist from Sweden’s IRLAB for $28 million upfront.  The deal gives Ipsen worldwide rights to the mid-stage drug – called mesdopetam – and puts the company on the hook for another $335 million in development, …

Ipsen tries again in Parkinson’s disease with $363m IRLAB deal Read More »

FDA staffers defend Aduhelm approval in JAMA editorial

Three FDA figures at the centre of the fallout over the approval Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm have defended their actions, arguing that to do otherwise would have left millions of patients in limbo for years. The trio say that the decision to approve Aduhelm (aducanumab) was extremely challenging as “evidence was strongly …

FDA staffers defend Aduhelm approval in JAMA editorial Read More »

How’s my driving? GPS tracking spots Alzheimer’s with 86% accuracy

Diagnosing Alzheimer’s disease is still a challenge, particularly in its earliest stages, but a new study suggests that subtle changes in behaviour whilst driving could serve as an early warning system. The researchers used GPS logging devices and machine learning as “digital biomarkers” to compare the driving of people who have preclinical Alzheimer’s but are …

How’s my driving? GPS tracking spots Alzheimer’s with 86% accuracy Read More »

Biogen builds MS pipeline via $125m deal with China’s InnoCare

Biogen has moved to shore up its besieged multiple sclerosis franchise by licensing a BTK inhibitor from Chinese biotech InnoCare currently in mid-stage clinical testing. InnoCare gets $125 million upfront in return for sharing rights to orelabrutinib, an orally-active BTK drug that is able to cross the blood-brain barrier and penetrate the central nervous system. …

Biogen builds MS pipeline via $125m deal with China’s InnoCare Read More »

US starts review of Aduhelm coverage amid fears of Medicare hit

The US government has started a review of how Biogen and Eisai’s pricey new Alzheimer’s disease therapy Aduhelm will be covered by Medicare, to see if a national strategy needs to be adopted. At the moment, the coverage for $56,000-a-year Aduhelm (aducanumab) is currently determined at the local level by Medicare administrative contractors representing 12 …

US starts review of Aduhelm coverage amid fears of Medicare hit Read More »

FDA whittles back Aduhelm approval amid concern over broad label

One of the criticisms levelled at the FDA over its approval of Biogen and Eisai’s Alzheimer’s disease drug Aduhelm was its decision to clear use of the drug in a broader group of patients than was included in clinical trials. Now, it has backtracked on that decision. The updated label for Aduhelm (aducanumab) says it …

FDA whittles back Aduhelm approval amid concern over broad label Read More »

ICER revises its view of Aduhelm’s price – but not by much

The Institute for Clinical and Economic Review (ICER) was very damning of Biogen’s new Alzheimer’s disease therapy Aduhelm when it issued its first report on the drug last month, and a swift update to its deliberations won’t be much comfort to the company. The cost-effectiveness watchdog has revised its calculation of a fair price range …

ICER revises its view of Aduhelm’s price – but not by much Read More »

ICER revises its view of Aduhelm’s price – but not by much

The Institute for Clinical and Economic Review (ICER) was very damning of Biogen’s new Alzheimer’s disease therapy Aduhelm when it issued its first report on the drug last month, and a swift update to its deliberations won’t be much comfort to the company. The cost-effectiveness watchdog has revised its calculation of a fair price range …

ICER revises its view of Aduhelm’s price – but not by much Read More »

Biogen abandons tau antibody for Alzheimer’s after phase 2 miss

Biogen has four other Alzheimer’s candidates in its clinical pipeline behind recently-approved Aduhelm, but one of them – anti-tau antibody gosuranemab – has just been canned. The decision comes on the back of the phase 2 TANGO study of gosuranemab (also known as BIIB092), which showed that the antibody was unable to show a benefit …

Biogen abandons tau antibody for Alzheimer’s after phase 2 miss Read More »

Consumer group seeks resignation of top FDA staffers over Aduhelm okay

With the first patient set to receive Biogen’s new Alzheimer’s drug Aduhelm in Rhode Island today, US consumer advocacy organisation Public Citizen is deeply unhappy about the FDA’s approval of the drug – and it wants the scalps of those responsible. In a letter to Secretary of Health and Human Services Xavier Becerra, the director …

Consumer group seeks resignation of top FDA staffers over Aduhelm okay Read More »

And then there were three: another FDA adcomm member quits over Aduhelm

The fallout over the FDA’s decision to approved Biogen’s Alzheimer’s therapy Aduhelm continues to be felt, with a third member of its advisory committee resigning in protest.  The latest to depart the FDA’s Peripheral and Central Nervous System Drugs panel is Aaron Kesselheim of Harvard Medical School, joining fellow committee members Joel Perlmutter and David …

And then there were three: another FDA adcomm member quits over Aduhelm Read More »

Double resignation over Aduhelm approval depletes FDA’s CNS adcomm

Two members of an FDA advisory committee have now resigned in protest over Monday’s approval of Biogen’s Alzheimer’s disease drug Aduhelm despite an overwhelming vote against doing so. Washington University neurologist Joel Perlmutter was the first to announce he was stepping down from the Peripheral and Central Nervous System Drugs Advisory Committee on the day …

Double resignation over Aduhelm approval depletes FDA’s CNS adcomm Read More »

Aduhelm approval could signal new era for CNS drugs; analysts

The unexpected approval and lofty pricing of Biogen’s Alzheimer’s therapy Aduhelm is clearly the biopharma event of the year so far, but what are the broader implications for the industry as a whole? Analysts at RBC Capital Markets say that the decision points to an unprecedented shift in position for the FDA when it comes …

Aduhelm approval could signal new era for CNS drugs; analysts Read More »

Bayer’s two-pronged cell/gene therapy assault on Parkinson’s enters clinic

Bayer subsidiary BlueRock Therapeutics has dosed the first Parkinson’s disease patient in a phase 1 trial of its cell-based therapy DA01, which aims to replenish the neurons lost in people with the neurodegenerative disorder. At the same time, the German group’s Asklepios BioPharma (AskBio) unit has started recruiting patients for a phase 1b trial of …

Bayer’s two-pronged cell/gene therapy assault on Parkinson’s enters clinic Read More »

FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. That was the damning conclusion of the influential Institute for Clinical and Economic Review (ICER) in the US to yesterday’s approval of Aduhelm (aducanumab), the first new treatment for Alzheimer’s …

FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag Read More »

Jubilation for Biogen, Eisai as FDA says ‘yes’ to aducanumab

Biogen and Eisai have defied the naysayers and secured an historic FDA approval for their amyloid-targeting antibody aducanumab as the first-ever disease-modifying treatment for Alzheimer’s disease. The accelerated approval from the US regulator has been given even though its own advisory committee comprehensively voted down the main study filed in support of the drug last …

Jubilation for Biogen, Eisai as FDA says ‘yes’ to aducanumab Read More »

Akili raises $110m to build its digital therapeutics pipeline

Digital health player Akili has raised $110 million fourth-round funding, backed by a number of pharma groups, as it works towards extending its product range beyond its flagship EndeavorRx app. EndeavorRx became the first and so far only approved prescription video game treatment in the US when it was cleared by the FDA last year …

Akili raises $110m to build its digital therapeutics pipeline Read More »

NICE says final ‘no’ to BMS’ Zeposia for multiple sclerosis

NICE has issued a final “no” to Bristol-Myers Squibb’s oral MS drug Zeposia (ozanimod), in a decision that prevents access for patients in England and Wales. This ruling means that there will be a divide in access to Zeposia in the UK, after the Scottish Medicines Consortium allowed funding in February for the drug in …

NICE says final ‘no’ to BMS’ Zeposia for multiple sclerosis Read More »

Exscientia starts trials of AI-designed Alzheimer’s drug

Exscientia has advanced a drug candidate for Alzheimer’s disease into human testing, the third clinical-stage project for the UK specialist in artificial intelligence (AI) based drug discovery.  The new molecule – called DSP-0038 – is being developed by Japan’s Sumitomo Dainippon Pharma (DSP), which is now starting a phase 1 trial in the US as …

Exscientia starts trials of AI-designed Alzheimer’s drug Read More »

CHMP backs Roche’s Enspryng for rare nerve disease NMOSD

Roche’s Enspryng has been recommended for approval in the EU for treating neuromyelitis optica spectrum disorder (NMOSD), extending the treatment options for people with the life-threatening rare disease.  The CHMP has backed the drug in patients aged 12 or more with NMOSD that tests positive for aquaporin-4 (AQP4) antibodies, a biomarker seen in around 80% …

CHMP backs Roche’s Enspryng for rare nerve disease NMOSD Read More »

Safety study pushes back phase 3 trial of Newron’s schizophrenia drug

Switzerland’s neurology specialist Newron must hold off starting a phase 3 study of its schizophrenia drug evenamide to complete a small study to show safety at a higher dose, causing a further delay to development. Clinical development has already been delayed by safety issues that arose unexpectedly in 2019 but the FDA agreed a plan …

Safety study pushes back phase 3 trial of Newron’s schizophrenia drug Read More »

FDA grew too close to Biogen during Alzheimer’s drug development, doctors say

The FDA got too close to Biogen during the development of the Alzheimer’s drug aducanumab, according to its own expert advisers who are urging the regulator to reject it in the coming weeks. With the deadline for a regulatory decision approaching for aducanumab in June, three doctors who took part in the expert advisory board …

FDA grew too close to Biogen during Alzheimer’s drug development, doctors say Read More »

Roche stops dosing in trial of Huntington’s disease hopeful tominersen

Roche has stopped dosing in a phase 3 trial of tominersen, a potential Huntington’s disease (HD) drug developed with Ionis, after a pre-planned review by independent experts.  The companies had been working on tominersen since December 2017, when Roche licensed it in from Ionis. There were high expectations for tominersen, which the companies hoped would …

Roche stops dosing in trial of Huntington’s disease hopeful tominersen Read More »

COVID-19 increased demands on carers’ wellbeing, study finds

COVID-19 has increased demands on informal carers and severely increased demands on their mental, physical and financial wellbeing, according to a global study. Embracing Carers is a global initiative led by Germany’s Merck KGaA and is focused on recognising and raising awareness about the role of informal carers. It intends to develop solutions with global …

COVID-19 increased demands on carers’ wellbeing, study finds Read More »

Ipsen’s John Chaddock on making neurotoxins a priority for healthcare systems

Injected neurotoxins can be incredibly potent in treating spasticity from neurological diseases, but the field doesn’t always get the attention it needs.  Ipsen’s John Chaddock tells us why the company is investing heavily in neurotoxin research and how he hopes to raise awareness among young scientists and the NHS. When the COVID-19 pandemic first hit, …

Ipsen’s John Chaddock on making neurotoxins a priority for healthcare systems Read More »

Early data back J&J and AC Immune’s Alzheimer’s jab

Shares in Swiss biotech AC Immune have risen sharply after it said a vaccine in development for Alzheimer’s disease (AD) hit the mark in a phase 1/2 trial.  ACI-35.030, partnered with Johnson & Johnson, is designed to stimulate the body to generate antibodies against tau protein, one of the factors though to play a role …

Early data back J&J and AC Immune’s Alzheimer’s jab Read More »

BMS’ MS pill gets funding in Scotland after rejection in England by NICE

Scotland’s drugs cost-effectiveness body has recommended Bristol-Myers Squibb’s Zeposia multiple sclerosis pill, setting a potential north-south access divide following a draft rejection in England by NICE last month. There are a range of MS drugs on the market but Zeposia does not have the common unpleasant gastrointestinal side effects that can occur with Biogen’s Tecfidera. …

BMS’ MS pill gets funding in Scotland after rejection in England by NICE Read More »

Competition for Neurocrine as Gocovri picks up new Parkinson’s indication

Adamas Pharmaceuticals’ Parkinson’s drug Gocovri has a new indication as an adjunctive treatment for levodopa/carbodopa in patients with Parkinson’s disease experiencing ‘off’ episodes. The new indication brings the drug into direct competition with Ongentys from rival Neurocrine Biosciences, which was approved for the same use last year. Adamas noted that Gocovri (amantadine extended release) already …

Competition for Neurocrine as Gocovri picks up new Parkinson’s indication Read More »

Biogen shares soar as FDA delays decision on aducanumab

The FDA has delayed its decision on aducanumab, the troubled Alzheimer’s drug from Biogen and Eisai by three months, raising hopes that it could be approved after all. Biogen’s share price jumped considerably after the news broke at the back end of last week, as an FDA rejection had been on the cards after an …

Biogen shares soar as FDA delays decision on aducanumab Read More »

Stress not a significant factor in migraine attacks, study finds

New findings from a digital study have challenged the belief that stress is a significant factor in triggering migraine attacks. Results came from a study by the digital health firm Curelator and the University of Calgary, who found that only 7.1% of patients had a majority of their attacks associated with increased levels of perceived …

Stress not a significant factor in migraine attacks, study finds Read More »

UCB backs epilepsy-focused digital heath startup Nile AI

Belgian drugmaker UCB has been steadily building its digital health expertise for several years, and that includes nurturing new projects. One of those is now being launched as a new company – Nile AI – that aims to improve the care of people with epilepsy. UCB is bankrolling Los Angeles-based Nile with €25 million (around …

UCB backs epilepsy-focused digital heath startup Nile AI Read More »

Could Lilly’s donanemab readout in Alzheimer’s boost Biogen’s prospects?

When Eli Lilly reported results for donanemab in Alzheimer’s disease earlier this week it was hailed as a rare win for the amyloid hypothesis, although there’s no shortage of candidates that have failed despite positive mid-stage trial results. Some analysts have intimated that given the small size of the study at just over 270 patients, …

Could Lilly’s donanemab readout in Alzheimer’s boost Biogen’s prospects? Read More »

RNAi biotech Atalanta debuts with $110m plus Biogen and Roche CNS tie-ups

US biotech Atalanta Therapeutics has come out of stealth mode backed with $110m from Biogen and Roche, who have also signed separate partnerships to develop new therapies for neurological diseases using RNA interference (RNAi) technology. While there are RNAi products on the marketplace, with Alnylam becoming the first company to get a product approved in …

RNAi biotech Atalanta debuts with $110m plus Biogen and Roche CNS tie-ups Read More »

Neurology’s Growing Need for Disposable Technologies

By Boris Goldstein, Co-Founder & Executive Chairman at Brain Scientific COVID-19 is known for its impacts on a patient’s respiratory system, but it has also been found to affect individuals in unique ways and with varying severity levels depending on their age, risk factors, and comorbidities. Several studies have recently shown that the development of …

Neurology’s Growing Need for Disposable Technologies Read More »

Angelini and Arvelle create neurology player with $960m merger

There’s a new player in the neurology and mental health drugs market after Italy’s Angelini Pharma merged with Switzerland’s Arvelle Therapeutics in a deal worth up to $960 million based around the anti-seizure drug cenobamate. Angelini is an international pharma company that is part of the privately-owned Italian Angelini Group, while Arvelle is focused on …

Angelini and Arvelle create neurology player with $960m merger Read More »

Clene goes public with gold-based neurology nanotechnology

Biotech Clene Nanomedicine has gone public with a mission to use nanotherapeutics that will use gold to treat devastating neurological diseases including Parkinson’s disease. Over the Christmas period Clene closed a reverse merger with Tottenham Acquisition I Limited, allowing shares to be publicly traded on the Nasdaq stock exchange. The US-based company says it aims …

Clene goes public with gold-based neurology nanotechnology Read More »

AI-designed serotonin tracker could help develop neurology drugs

A serotonin sensor designed using Artificial Intelligence (AI) could help scientists study sleep and mental health and potentially find new neurology drugs. The US National Institutes of Health said that the research it had co-funded used AI to transform a bacterial protein into a new research tool. It is hoped that the protein, which “catches” …

AI-designed serotonin tracker could help develop neurology drugs Read More »

Novartis buys neurology biotech Cadent for up to $770m

Novartis is to buy neuroscience drugs firm Cadent Therapeutics in a deal worth up to $770 million. The big Swiss pharma already has a presence in neurology with its multiple sclerosis drug Gilenya (fingolimod) and the more recently approved Aimovig (erenumab). With the acquisition of Cambridge, Massachusetts-based Cadent, Novartis gains rights to a portfolio of …

Novartis buys neurology biotech Cadent for up to $770m Read More »

9th Annual Neurodegenerative Drug Development Summit

The 9th Neurodegenerative Drug Development Summit is the industry’s definitive and unrivalled forum focused on revealing hot and promising pockets of innovation in drug discovery for neurodegenerative diseases and combating translational challenges by shining a light on pioneering companies leading the way to meet this dire medical need. Building on the success of last year’s meeting, this …

9th Annual Neurodegenerative Drug Development Summit Read More »

Lilly pays up to $1.04bn for neurology gene therapy biotech Prevail

Eli Lilly has acquired Prevail, a biotech focusing on gene therapies for neurodegenerative diseases including Parkinson’s, in a deal potentially worth more than $1 billion. The big US pharma is to pay up to $1.04 billion to buy Prevail, paying $22.5 per share up front plus a $4 contingent value right (CVR) to sweeten the …

Lilly pays up to $1.04bn for neurology gene therapy biotech Prevail Read More »

Swiss start-up Noema raises $59m to develop neurology drugs offloaded by Roche

Swiss biotech Noema has raised 54 million Swiss francs ($59m) to develop four neurological disorder drugs licensed in from Roche. The company is developing four phase 2 drugs brought in from Roche after the big Swiss pharma decided somebody else should take the risk of developing them. Roche, which decided the products were surplus to …

Swiss start-up Noema raises $59m to develop neurology drugs offloaded by Roche Read More »

Eisai forges CNS alliance with UK’s Wren Therapeutics

Japanese drugmaker Eisai has teamed up with UK biotech Wren Therapeutics on an R&D programme seeking drugs for neurodegenerative disorders. The two companies will focus their efforts on alpha-synuclein, a pathway that has been implicated in disorders such as dementia with Lewy bodies (DLB) and Parkinson’s disease (PD). DLB and PD are both so-called synucleinopathies, …

Eisai forges CNS alliance with UK’s Wren Therapeutics Read More »

Biogen bulks up pipeline with Sage drugs in $3bn deal

With the prospects for its Alzheimer’s drug aducanumab still up in the air, Biogen has moved to shore up its late-stage pipeline with a $3 billion licensing deal with Sage that adds drugs for depression and neurological disorders. The licensing agreement gives Biogen rights to Sage’s zuranolone (SAGE-217) for psychiatric disorders including depression, and SAGE-324 …

Biogen bulks up pipeline with Sage drugs in $3bn deal Read More »

FDA panel unimpressed with data for Alzheimer’s drug aducanumab

The FDA may have been minded to approve Biogen and Eisai’s Alzheimer’s candidate aducanumab, but its clinical advisors have little doubt that the evidence for the drug is lacking. The much-anticipated advisory committee meeting held on Friday to discuss the marketing application for aducanumab proved to be a fractious affair, with both the companies’ data …

FDA panel unimpressed with data for Alzheimer’s drug aducanumab Read More »

China’s Green Valley prepares US trial of Alzheimer’s drug inspired by algae

As an influential panel of FDA-appointed experts prepares its verdict on Biogen’s Alzheimer’s drug, a little known China-based pharma is hoping to succeed where big name rivals have failed and develop a drug that is effective against the disease. For almost two decades there has been no progress with new therapies for Alzheimers – the …

China’s Green Valley prepares US trial of Alzheimer’s drug inspired by algae Read More »

Novartis’ Aimovig tops topiramate in migraine face-off

Novartis’ injectable migraine prevention antibody Aimovig has been shown to be more effective than topiramate – a go-to oral therapy for people with chronic migraine – in a head-to-head trial. The HER-MES trial found that Aimovig (erenumab) was more effective at preventing migraine attacks and also better tolerated than topiramate, a generic epilepsy drug which …

Novartis’ Aimovig tops topiramate in migraine face-off Read More »

Salvia’s migraine implant could be breakthrough, says FDA

An implantable neurostimulation migraine device from Salvia BioElectronics has gained Breakthrough Device Designation from the FDA. Traditional neurostimulation systems are not designed to be compatible with the anatomy of the head, so Netherlands-based Salvia has developed flexible bioelectronic foils (pictured) that could be inserted below the skin in a minimally invasive procedure. Breakthrough Device designation …

Salvia’s migraine implant could be breakthrough, says FDA Read More »

NICE changes its mind on Novartis’ progressive MS drug Mayzent

UK cost-effectiveness agency NICE has backed Novartis’ Mayzent for secondary progressive multiple sclerosis (SPMS), after turning it down earlier this year in draft guidance. The change of heart means Mayzent (siponimod) becomes the first oral disease-modifying therapy to be recommended for NHS use in SPMS patients with active disease, defined as relapses or evidence of …

NICE changes its mind on Novartis’ progressive MS drug Mayzent Read More »

Axovant pushes on with Parkinson’s gene therapy, despite investor cynicism

Axovant has said it plans to continue developing its Parkinson’s Disease gene therapy after reporting supportive data from a small cohort of patients from a phase 2 trial. However shares in Axovant were down sharply after the announcement because of market sentiment that the New York biotech had been selective with the data it had …

Axovant pushes on with Parkinson’s gene therapy, despite investor cynicism Read More »

Patient from the USA Underwent Spinal Discectomy Surgery in Turkey

Mr. James Evans suffered from serious back pain and he was taking pain injections to ease his pain. After the prolonged use of pain injections, they also stopped working. He consulted his Chiropractor in the USA he told him to get the spinal surgery done for his back pain. Mr. James had a discussion with …

Patient from the USA Underwent Spinal Discectomy Surgery in Turkey Read More »

Mission successful for Novartis after FDA approves ofatumumab in MS

It’s mission accomplished for Novartis after the FDA approved ofatumumab for multiple sclerosis, completing a project where the former cancer drug has been repurposed. The FDA approved ofatumumab under the brand name Kesimpta for people living with relapsing forms of multiple sclerosis. Kesimpta will have a list price of around $83,000 a year, which the …

Mission successful for Novartis after FDA approves ofatumumab in MS Read More »

Roche takes on Alexion as FDA approves satralizumab in NMOSD

The FDA has approved Roche’s satralizumab for the rare autoimmune disorder Neuromyelitis Optica Spectrum Disorder (NMOSD), under the brand name Enspryng. Roche is taking on Alexion’s blockbuster Soliris (eculizumab), which was approved in NMOSD last year and in June Viela Bio, a spinoff from AstraZeneca, also won approval for another rival, Uplinza (inebilizumab). The big …

Roche takes on Alexion as FDA approves satralizumab in NMOSD Read More »

Bayer adds menopause drug to pipeline with KaNDy acquisition

Bayer is to buy UK-based KaNDy Therapeutics in a deal worth more than $800 million, adding the biotech’s menopause drug to its women’s health pipeline. Bayer will pay $425 million up front and potential milestone payments of up to $450 million until launch, followed by potential undisclosed “triple digit million” milestone payments once the drug …

Bayer adds menopause drug to pipeline with KaNDy acquisition Read More »

Roche takes on pricey rivals as FDA approves SMA drug

Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). Evrysdi is the third treatment approved for SMA, an ultra-rare muscle wasting disease that can begin in early childhood, after Biogen’s Spinraza (nusinersen) and Novartis’ Zolgensma (onasemnogene abeparvovec). But Spinraza costs $750,000 in the …

Roche takes on pricey rivals as FDA approves SMA drug Read More »

Biogen signs $2.1 billion Parkinson’s disease deal with Denali

Biogen has bought a licence to co-develop and co-market potential Parkinson’s disease drugs with US biotech Denali, in a deal worth more than $2.1 billion. Denali has been working on small-molecule compounds capable of crossing the blood-brain barrier and Biogen has bought a licence to co-develop and co-market compounds known as LRRK2 inhibitors in Parkinson’s …

Biogen signs $2.1 billion Parkinson’s disease deal with Denali Read More »

Roche doubles down on tau for Alzheimer’s, licensing UCB drug for $120m

Roche already has one Alzheimer’s candidate in its pipeline targeting tau, but has added a second via a deal with Belgian drugmaker UCB worth up to $2 billion. The Swiss pharma group is paying $120 million upfront for exclusive global rights to UCB0107, an anti-tau antibody that is in a phase 1 trial in another …

Roche doubles down on tau for Alzheimer’s, licensing UCB drug for $120m Read More »

Eli Lilly’s P-tau217 Blood Test Demonstrate High Accuracy in Diagnosis of Alzheimer’s Disease

Shots: The study involved 1402 patients across 3 cohorts: a) 81 patients in Arizona (34 with AD and 47 without), b) 699 in Sweden (301 with no cognitive impairment, 178 with mild cognitive impairment, 121 with AD dementia and 99 with other neurodegenerative diseases) and c) 622 in Colombia (365 with E280A mutations and 257 …

Eli Lilly’s P-tau217 Blood Test Demonstrate High Accuracy in Diagnosis of Alzheimer’s Disease Read More »

Roche and UCB Collaborate to Develop UCB0107 for Alzheimer’s Disease

Shots: UCB to receive $120M and is eligible to receive $2B as cost reimbursement, development, and commercial milestones as well as royalties on sales of the therapies, if Roche proceeds the clinical development. Roche to get an exclusive license to develop and commercialize UCB0107 for AD UCB to fund and perform a POC study in …

Roche and UCB Collaborate to Develop UCB0107 for Alzheimer’s Disease Read More »

FDA approves Jazz Pharmaceuticals’ narcolepsy therapy

The FDA has approved Jazz Pharmaceuticals’ sleep disorder drug Xywav, to treat daytime sleepiness in patients with narcolepsy, offering a regime with less sodium than standard therapy. Xywav (calcium, magnesium, potassium, and sodium oxybates) is an oral solution that has been approved in patients aged seven or older with narcolepsy. Narcolepsy is a neurological disorder …

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Pandemic and currency headwinds hurt Roche in first half

Roche has announced half-year results showing the COVID-19 pandemic affected sales of its key products, with currency headwinds also weighing on revenues. The Swiss pharma’s figures came shortly after its arch-rival Novartis conceded that it had hit similar problems as the pandemic meant fewer patients started new courses of its drugs. Four of the company’s …

Pandemic and currency headwinds hurt Roche in first half Read More »